NOVASPINE POWERED SUCTION PUMP PRO-1

K062456 · Novaspine, LLC · OMP · Oct 16, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062456
• Device Name: NOVASPINE POWERED SUCTION PUMP PRO-1
• Applicant: Novaspine, LLC
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.

Device Story

Portable, battery-powered aspiration pump; provides continuous or intermittent negative pressure (max 200 mmHg) for removal of secretions, blood, and body fluids. Used in surgical or bedside settings by clinicians. Device consists of pump/battery unit and disposable components (canister, tubing, connectors, filters). Rechargeable NiMh battery; external power port. Output is negative pressure suction; healthcare providers monitor fluid collection in canister to manage patient drainage and promote wound healing or clear airways.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable powered suction pump; 2.8 kg; 290mm x 359mm x 130mm. Performance: 9 L/min flow, 200 mmHg max vacuum, 35 dba noise. Power: Rechargeable NiMh battery with external power/charger port. Operation: Continuous and intermittent modes. Components: Integrated pump/battery unit, disposable collection canister, tubing, connectors, and filters.

Indications for Use

Indicated for patients requiring suction for wound healing promotion or aspiration/removal of surgical fluids, tissue (including bone), gases, bodily fluids, or infectious materials from airways or respiratory support systems in surgical or bedside settings.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Kinetic Concepts AmbuVAC (K971548)
• Blue Sky Medical Group, Inc. Versatile 1 Wound Vacuum System (K042134)
• NovaSpine LLC SIMEX Suction Pump (K061133)

Submission Summary (Full Text)

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# Nova®Spine LLC

062456

page

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| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safe Medical Devices Act of 1990 (SMDA) | |
| 510(k) Summary OCT 16 20 | |
| Date prepared: | September 27, 2006 |
| Name of Firm: | NovaSpine LLC<br>15 Heritage Court<br>Tarrytown, NY 10591<br>Telephone: [phone]<br>Fax: [phone]<br>E-mail : [e-mail] |
| 510(k) Contact: | Dina L. Weissman, J.D.<br>P.O. Box 205<br>Derby CT 06418<br>Telephone: [phone]<br>Email: [e-mail] |
| Manufacturer: | Asskea (Simex) Medizintechnik, GmbH<br>Schlefweg 25, D-99718, Greussen, Germany |
| Trade Name: | NovaSpine Powered Suction Pump PRO-I |
| Common Name: | Powered Suction Pump |
| Classification: | FDA 21 CFR 878.4780<br>Powered Suction Pump<br>Class II, Code: BTA |
| Device Product Code | BTA - Pump, Portable, Aspiration, (Manual or<br>Powered) |
| Substantial Equivalency | Kinetic Concepts K971548<br>"AmbuVAC"<br>Blue Sky Medical Group, Inc. K042134<br>"Versatile 1 Wound Vacuum System"<br>NovaSpine LLC K061133<br>"SIMEX Suction Pump" |
| Indications for Use | The NovaSpine Powered Suction Pump PRO-I is<br>indicated for patients who would benefit from a suction<br>device particularly as the device may promote wound<br>healing or for the aspiration and removal of surgical<br>fluids, tissue (including bone), gases, bodily fluids or<br>infectious materials from a patient's airway or<br>respiratory support system either during surgery or at the<br>patient's bedside. |
| Page 1 of 2 | |

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**Nova Spine LLC**

Kc62456 xaye

PO Bax 969 Elmsford, NY 10523

### Device Description:

The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model:

| Table 1 | |
|---------|----------------------------------------|
| 1. | Suction: 9 liters/min, |
| 2. | Maximum Vacuum: 200 mmHg |
| 3. | Noise: 35 dba, |
| 4. | Weight: 2.8 kg |
| 5. | Operation: Continuous and Intermittent |
| 6. | Dimensions: 290mmX359mmX130mm |

The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger.

The NovaSpine Powered Suction Pump PRO-I is composed of two parts:

- 1. The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
- 2. The consumable/disposable components such as:
- Collection canister (secretion container), a.
- Related hoses (tubing) b.
- Hose connectors c.
- d. Filters
- Other accessories as detailed in the operating manual e.

### Basis For Substantial Equivalence:

This product is substantially equivalent to similar technical specifical specifications currently on the market such as:

> Kinetic Concepts K 971548 Ambu VAC Blue Sky Medical Group, Inc. K042134 Versatile 1 Wound Vacuum System NovaSpine, LLC K061133 SIMEX Suction Pump

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

APR -7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NovaSpine, LLC % Weissman Law Firm Ms. Dina L. Weissman. J.D. P.O. Box 205 Derby, Connecticut 06418

Re: K062456

Trade/Device Name: NovaSpine Powered Suction Pump PRO-1 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 18, 2006 Received: August 23, 2006

Dear Ms. Weissman:

This letter corrects our substantially equivalent letter of December 16, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other

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#### Page 2 - Ms. Dina L. Weissman

Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

R.C. Hatto

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number:

### Device Name:

# NovaSpine Powered Suction Pump PRO-I

## Indication for Use:

The NovaSpine Powered Suction Pump PRO-I is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing or for the aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from a patient's airway or respiratory support system either during surgery or at the patient's bedside.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number_K062456